Clinical Study Manager in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 10/2/2019

Job Snapshot

Job Description

Job ID: BEC016071

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Join a growing, ambitious team focused on supporting top projects in Beckman Coulter’s largest business.  Beckman Coulter’s Chemistry and Immunoassay business is seeking an experienced Clinical Study Manager.  Reporting to the Head of Clinical Affairs, this role is integral to the business in maintaining and growing the product portfolio by generation of clinical evidence to support product registration, post-market reporting, and marketing strategy.  
Combine your extensive knowledge in clinical research and our proprietary work processes in driving continuous process improvement and developing clinical team members.  At Beckman Coulter, we Help Realize Life’s Potential by delivering the best diagnostic products to the laboratories, clinicians and patients who need them.
  • Key Responsibilities:
  • Representing the Clinical function in collaboration with a cross-functional project core team to develop and execute:
  • The Product Evidence Strategy plan
  • A Global Clinical plan
  • Successful negotiations with government regulatory agencies such as the U.S. Food and Drug Administration
  • Leading a clinical project team consisting of clinical operations, biostatistics, and data management experts to complete key clinical deliverables, such as:
  • Study protocols
  • Monitoring plans 
  • Data management plan and electronic Case Report Forms
  • Statistical analysis plan
  • Qualifying potential study investigators
  • Negotiating study contracts and budgets
  • Performing clinical study monitoring activities consistent with Good Clinical Practice standards
  • Compliant, high-quality study data and final study reports
  • Facilitating publication of clinical data in professional journals and company literature
  • Providing work direction and mentorship to developing Clinical Research Associates 

Job Requirements


  • Education / Experience:
  • Bachelor’s degree with 9+ years’ experience, Master’s with 7+ years’ experience, or Doctoral degree with 4+ years
  • Experience crafting, organizing, and conducting complex multicenter global clinical trials for Medical Devices or deep technical knowledge of In-Vitro Diagnostic product development with direct experience in characterization, verification or clinical validation testing at external sites
  • Experience reviewing and summarizing clinical data analyses for study reports and publication
  • Other device or pharmaceutical experience in cardiac, hepatic, thyroid, reproductive disease is a plus
  • Able to travel up to 35%

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.